1. API Listing:
Current API listing occurs independently from drug listing of finished product. Prior to product launch, an iminent approval imporation (IAI) or a Pre-launch approval Importation request is submitted to the Agency to prevent detainment of product at the border. With SPL r.4, drug listing of API is included with content of labeling and the final package components are submitted after approval of the drug. When would the SPL be submitted with drug listing information? This question needs to be brough to FDA and the logistics need to be figured out.
2. Product Delisting:
Products that are going to be discontinued, products that should have been delisted but have not, and products under manufacturing sites that have a completely separate Labeler code will need to be delisted. This will result in a massive delist of products. If products are delisted at once, there may be a time gap between when they are delisted and when the SPL r.4 file will be submitted with the new drug listing information. This can cause problems at the border with products entering the country.
Delisting of products was discussed at the Generics Sub group meeting
Companies will need to contact FDA at spl@fda.hhs.gov to indicate intentions of delisting. A list may be provided to the Agency of all the products that will be delisted and the effective time the delisting will go into effect. This is only available during the pilot period.
3. General listing questions:
a. The FDA Drug Firm Annual Registration Status Database now includes DUNS numbers. This will assist companies in ensuring consistency when listing an establishment. Additionally, the type of operations conducted at the establishment can be beneficial as well.
b. How does FDA border verify multiple end users for 1 API.Is there documentation that is needed? The scenarios that were created and presented by FDA say that the relationship with the establishment needs to be defined. Need to clarify that nothing additional is needed.
Effective time is applicable to each section of the SPL file.
Drum labels will be needed if API is being listed in 1 SPL file.
Preferred way to drug list a product is to list all manufacturers (establishments) for each product in one SPL file. Source NDC is intended for a repacker and not for situations where there is a business relationship.
API manufacturing is not differentiated on the SPL form.
Current API listing occurs independently from drug listing of finished product. Prior to product launch, an iminent approval imporation (IAI) or a Pre-launch approval Importation request is submitted to the Agency to prevent detainment of product at the border. With SPL r.4, drug listing of API is included with content of labeling and the final package components are submitted after approval of the drug. When would the SPL be submitted with drug listing information? This question needs to be brough to FDA and the logistics need to be figured out.
2. Product Delisting:
Products that are going to be discontinued, products that should have been delisted but have not, and products under manufacturing sites that have a completely separate Labeler code will need to be delisted. This will result in a massive delist of products. If products are delisted at once, there may be a time gap between when they are delisted and when the SPL r.4 file will be submitted with the new drug listing information. This can cause problems at the border with products entering the country.
Delisting of products was discussed at the Generics Sub group meeting
Companies will need to contact FDA at spl@fda.hhs.gov to indicate intentions of delisting. A list may be provided to the Agency of all the products that will be delisted and the effective time the delisting will go into effect. This is only available during the pilot period.
3. General listing questions:
a. The FDA Drug Firm Annual Registration Status Database now includes DUNS numbers. This will assist companies in ensuring consistency when listing an establishment. Additionally, the type of operations conducted at the establishment can be beneficial as well.
b. How does FDA border verify multiple end users for 1 API. Is there documentation that is needed? The scenarios that were created and presented by FDA say that the relationship with the establishment needs to be defined. Need to clarify that nothing additional is needed.
c. Points made at the drug listing presentation:
spl@hhs.fda.gov